From consesus to cure

AWARENESS | MEMBER OF PARLIAMENT IN PORTUGAL, HEAD OF PUBLIC HEALTH, CATHOLIC UNIVERSITY OF PORTUGAL

When Dr Ricardo Baptista Leite set out to persuade Portugal’s minister of health to make a new generation of highly effective treatments for the Hepatitis C virus available to anyone who needed them, Dr Leite knew he could not achieve this goal alone. The country was facing serious fiscal constraints in 2013. And many people, unlike Dr Leite, did not know how game-changing the new treatments could be.

To build awareness and consensus around the idea of having the government pay for the new treatments, Dr Leite devised a methodology to involve three key groups of stakeholders: 1) decision-makers such as the minister of health; (2) officials who would implement the government’s policies on HCV, such as healthcare managers and others in regulatory agencies; and (3) patients and their families, who would have to live with the policies. “For true change to happen, we needed to get everyone on board,” Dr Leite says.

As head of public health at the Catholic University of Portugal and a member of Parliament, Dr Leite’s prominence in the community allowed him to personally reach out to the stakeholders to invite them to join a working group to draft Portugal’s response to the HCV crisis. At the time, The World Health Organisation estimated that HCV prevalence in Portugal was 1-1.5%. Although some potential participants were initially unaware of how vital their involvement was, he ultimately persuaded 30 to join the group.

To ensure effectiveness, the working group operated under a few ground rules. “We decided that nobody would be paid, so there would be no commercial bias,” recalls Dr Leite. A small steering committee would be responsible for the final text of the recommendations, so participants knew they could speak freely. “This was extremely important,” he says. “To have someone representing the Ministry of Health, it’s extremely important to make them feel comfortable.”

“For true change to happen, we needed to get everyone on board.”

The working group held three primary meetings. At the first gathering, the working group strived to establish consensus on the current HCV situation in Portugal. At the second gathering, known as the “Dream Meeting”, participants were asked how they would change Portugal’s response to HCV if they had no financial or other constraints. “This is an important icebreaker,” says Dr Leite. “When you talk with public servants, the first thing they say is they don’t have the money to do something.” At the final meeting, the working group focused on realising their ideal elimination-oriented scenarios situated in a real-world setting with actual constraints.

The group assigned consensus levels of A, B and C to new ideas, with A being the highest. Recommendations that received an A made it into the landmark consensus paper executive summary that the group released in 2014; this paper recommended an integrated approach, from prevention to diagnosis, linkage to care and the use of the new treatments as part of the HCV elimination strategy. “At the end of the day, we were capable of agreeing on a lot of things,” says Dr Leite. One idea that achieved complete consensus was creating a central registry of HCV patients—a concept that has since been realised, with more than 13,000 people currently registered.

But Portugal still had a long way to go before covering treatment for people with HCV. The minister of health, waiting for new treatments to increase financial competition between pharmaceutical companies, was unready to act. Members of the working group became increasingly vocal about the need to act more quickly. “All of a sudden, we had some of the most influential people in our country become soldiers for the cause,” recalls Dr Leite. “Many of the stakeholders were defending the same things I was. That began to build a lot of pressure.”

“At the end of the day, we were capable of agreeing on a lot of things.”

The working group’s efforts culminated in a dramatic moment at a public hearing in February 2015 held by the minister of health at the Portuguese Parliament. Dr Leite attended along with HCV patients pushing for access to new treatments.

One patient with cirrhosis needed new drugs to survive. “In the middle of that hearing, he stood up and started screaming at the minister, ‘Don’t let me die,’” recalls Dr Leite. Two days later, the minister announced that the new drug would be fully subsidised for all patients in Portugal.

In his role at Catholic University, Dr Leite is now advising specialists for other diseases on how to use the consensus-building methodology to achieve access to new medical approaches, most recently in the fields of oncology and neurology. He is also working on recommendations for a national action plan for HCV, one that will help improve access for injectable drug users and inmates. “Treatment is getting easier and easier,” Dr Leite says. By October 2017, he plans to release a digital policy dashboard that will allow users to calculate a country’s likelihood of eliminating HCV by 2030 based on its existing policies. “We’ll hopefully create a competitive environment between countries to push things forward,” he says.